Patient Reported Outcomes – Choosing Appropriate Metrics from a Still-Evolving Toolset

Patient Reported Outcomes

Choosing Appropriate Metrics from a Still-Evolving Toolset

By Wes Chapman, Mike Choukas, Charles Hutchinson PhD, Steve Maker, Mario Martinez

Purpose

This paper defines a set of criteria for choosing Patient Reported Outcome metrics for use in oncology, and lists five PROs the authors found suitable for further study and trial. The criteria should be useful for testing the suitability of new metrics as they become more sophisticated and more accepted in clinical care and in oncology in particular.

Background

Patient reported outcomes (PROs) are widely recognized as an important component in measuring healthcare outcomes. The National Institutes of Health (NIH), Food and Drug Administration (FDA), and Centers for Medicare and Medicaid Services (CMS), in their various programs, have all specified the use of PROs in determining effectiveness, safety, or value of a particular clinical program, pathway, medical device, or drug. This makes clear sense; the goal of healthcare is to improve the health of patients, and only the patients themselves can tell us how well they feel, before, during, and after the treatment.

As opposed to objective measures of health (blood pressure, bone density, lung capacity, etc.), which doctors or nurses can measure and report, PROs depend on answers patients provide to subjective questions about physical, mental, and emotional health: how much pain they’re feeling, how much energy, how much anxiety. In fact, there are some conditions – gastrointestinal distress, depression – where PROs are the only available measure without additional testing. PROs also examine the effects of these feelings on functional aspects of life; for example, how much their pain has affected their work, play, social life, and so on.

PROs are obtained through short surveys, either self-administered by the patient or through an interview, and usually take the form of rating scales or yes/no questions; for example:

I have pain … Not at All – A little bit – Somewhat – Quite a bit – Very much

PROs measure a patient’s sense of health and well-being, now and over time, indicating whether a particular treatment has been effective. They can also be combined with measures of service (During this hospital stay, how often did nurses explain things in a way you could understand? Never – Sometimes – Usually – Always) to measure a patient’s experience and satisfaction with the treatment they received, and they can be aggregated with other patients’ answers to provide a measure of the total process the patient went through, as well as a rating of the hospital or clinic that provided the treatment.

                                                           
Cartoon by xkcd at http://xkcd.com/883/

Finally, PROs can be an important source of metrics for quality improvement at every level: the individual case, the pathway, the physician, the team, and the facility. Given this level of usefulness, we should expect to find a robust set of PROs (or metrics derived from PROs, sometimes referred to as PROMs) that physicians and clinics can choose from to suit their particular needs.

Unfortunately, this doesn’t seem to be the case.

Still in Their Adolescence

The current state of PROs is best described in an expert commentary posted May 14, 2012 on the website of the National Quality Metrics Clearinghouse (NQMC):

For more than 40 years … outcomes have had a central role in how high-quality health care is conceptualized. In an era in which individualized or personalized care, patient-centered care, patient-centered medical homes, and “patient-important” outcomes are increasingly invoked as critical aims for the U.S. health care system, using patient-reported outcomes (PROs) in quality assessment and improvement schemes seems crucial.

The significance of this view has not yet, it would seem, reached any substantial level of practical application. –Kathleen N. Lorh, PhD

Dr. Lohr, a researcher with RTI International at Research Triangle Park in North Carolina, has worked in the field of healthcare quality metrics for over two decades. She is affiliated both with the PROMIS Health Organization (a nonprofit foundation that develops and administers PROs), and the Core Editorial Board for the National Quality Measures Clearinghouse and the National Guideline Clearinghouse. She bases her statement not only on her experience, but on the simple fact that “…even though NQMC has more than 360 outcome measures (as of early 2012), the Clearinghouse has very few patient-reported outcome measures – those directly salient to and reported by patients about the end results of health care.” By her count, somewhere between 20 and 40 measures at most involve PROs. She can’t be more definite because the NQMC’s search functions don’t allow a simple means to find PROs, which is, in itself, a statement about the status of PROs.

Dr. Lohr points out that thousands of PROs exist, but few of the developers have made an effort, or succeeded, in submitting their measures to the NQMC for approval and inclusion. She analyzes why this is the case, and provides a solution that revolves around the NQMC’s requirements for inclusion. Both her suggestions and the editor’s response imply that most developers of PROs would not have any trouble getting their measures approved. Yet that hasn’t been happening. Given the requirements from NIH, FDA, and CMS, this seems remarkable.

Barriers to Endorsement

It’s significant to note that CMS has endorsed only one PRO measurement tool, the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), which is actually far more focused on hospital services than it is on patient health and well-being. Questions on the HCAHPS range from “how often did the nurses treat you with courtesy and respect” to “how often was the area around your room quiet at night”. It does not ask if the patient is currently in pain, anxious, nauseous, able to walk or work. It does not compare the patient’s current state with their previous state, nor with their expectation of how they should feel after going through treatment. It doesn’t measure outcomes, it measures process, and a limited part of the process at that: just a few variables that are universal to every hospital experience, heavily weighted toward hospitality rather than clinical treatment.

Why is this significant? Because the HCAHPS is now a key piece in the payment formula for Medicare and Medicaid patients. Hospitals and clinics are driven to use the HCAHPS in order to be paid, not because it’s an effective tool in quality improvement. Until CMS requires other PROs for a wider range of situations and more related to the health state of the patient, there will be less incentive for the industry to start using them. But this is not the only barrier.

Most PROs Were Not Designed for Clinical Care

Many PROs, if not most, were developed for use in clinical trials, not for use in standard clinical care. Using PROs in trials can be vitally important, of course, helping to determine if new treatment pathways are beneficial from the patient’s perspective. Because these PROs have been validated in the clinical trial arena, however, some would argue that they are not reliable quality metrics for use in clinical treatment. This ignores the fact that the patient’s experience is very much the same in both settings, and the effects of the disease vary only to the extent that treatment pathways vary. In oncology, there will still be the same array of symptoms to deal with – pain, nausea, anxiety, depression, fatigue, sleeplessness, and so on – with slight variations depending on the specific cancer. And the questions you want to ask the patient about their physical, mental, and emotional state are the same.

Most PROs Are Not Disease Specific

The large majority of PROs are designed to assess the general state of a patient’s well-being. This makes sense; the health effects that PROs attempt to measure are caused by most diseases. A migraine, for example, is far more than a pain in the head. But it is true that certain diseases have a spectrum of effects that are not all covered in a general health assessment survey. Cancer and its treatment can cause pain, nausea, weakness, vertigo, confusion, weight loss, hair loss, fatigue, sleeplessness, anxiety, depression, and more. However, the extreme cases do seem to be covered. There are PROs for general cancer and some specific cancers, as well as for headaches, asthma, hepatitis, HIV, and more. And these tools can be combined with a general health PRO to generate a more compete picture of health and well-being.

Many PROs Conflate Process with Outcome

This seems to be particularly true of hospital rating tools, such as the HCAHPS and the many commercially offered tools that have the CAHPS as their core metric set. As we said above, these tools include quite a few measures of hospitality and service during treatment, rather than measures of the quality of clinical pathways and their before-and-after effects on the patient. Or they mix the measures in such a way that it is difficult to separate hospitality from treatment and process from outcome. While it is undoubtedly true that the total healthcare experience, from ease of parking to post-discharge follow-up, has an effect on the patient’s well-being and satisfaction, providers are rightfully concerned that too much emphasis can be placed on factors that are only marginally important to health outcomes.

PROs Imply Criticism of Doctors and Clinics

Healthcare providers are not always happy to see their work measured in such a personal and transparent way. As one doctor put it:

“In medicine, we are used to confronting failure … What we’re not used to doing is comparing our records of success and failure with those of our peers … the truth is that we have had no reliable evidence about whether we’re as good as we think we are.” –Atul Guwande, M.D.; Better: A surgeon’s notes on performance (p.207); 2007, Picdor/Henry Holt & Company.

PROs provide that evidence, and they have special weight, because they are essentially spoken in the patient’s own words. Doctors and the facilities where they work not only cringe at the potential criticism, they worry that a poor rating will drive away business. Dr. Gawande’s book shows at least one example where that doesn’t seem to be the case, and where transparency has led to quality improvement in all of the clinics being rated, including those already at the high end of the curve. It’s important to note, though, that the PROs must be appropriate to the situation and, to state the key point of any quality metric, they must be analyzed, understood, and acted on. Doctors, nurses, and other staff must be educated about the benefits to both patient and provider that accrue from the quality improvement gains made possible with PROs; not just higher ratings, but also better treatment pathways, more patient involvement, better palliation, and better outcomes all around.

Criteria for Choosing the Right PROs

In a previous paper, we outlined a taxonomy of organizations that endorsed clinical pathways and metrics in oncology. Our selection criteria there was based on the Anna Karenina Principle, which states that the key organizations will be the only ones that meet a specific set of must-have characteristics. PROs require a less restrictive approach. The range of uses to which they are put, along with their current evolving state of development and acceptance in healthcare, is such that no one set of criteria would identify PRO instruments that fit every application. That said, we have been able to define a set of five characteristics that apply to many PROs in varying degrees. In some cases, it’s a loose fit, but the importance of each criterion to any given application can be considered when making choices.

Our five characteristics are:

1)      Applicable to Oncology – The questions cover a range of negative symptoms associated with cancers, as well as measures of general health and functionality. Some PROs, such as the FACT-G, are designed specifically for oncology and rate very highly here. Others, such as the SF-36 are general health assessment tools, but do ask about pain, anxiety, and other symptoms applicable to Oncology.

2)      Broadly used – The PRO instruments have been used in many institutions or trials. (Since so few have been endorsed by CMS, AHRQ, or NQF, this provides a reasonable measure of acceptability and potential for endorsement.) It can be difficult to determine if a particular PRO instrument is widely used in clinical care without relying on unsupported claims made by vendors.

3)      Well validated – The PRO instrument tests well for both validity (the measure is associated with what it purports to measure) and reliability (the measure is free from random error). Note that, in some cases, the only statements of validity and reliability that are easy to find come from the vendor of the instrument.

4)      Easy to use ­– The survey is brief and easy to understand and complete by a person under the stress of treatment. The FACT-G, for example, has 28 questions, while the Symptom Impact Profile has over 100, and a long set of detailed instructions. Alternative methods of administration, such as by interview, by phone, with assistance, or via computer (tablet, online, etc.) can simplify a long instrument or complicated set of questions (e.g., if the answer is Yes, jump to question 13).

5)      Clinically Useful – That is, the measure can be used to immediately adjust treatment to improve the patient’s state of health. In an Anna Karenina universe, the HCAHPS would not be welcome in the happy family of PROs.

A Selection of PROs for Oncology ACOs

Our projects require PROs suitable for use in accountable care organizations (ACOs) focused on clinical oncology. Using our five criteria, we have selected four PROs that fit the critera fairly well, and have decided to include one outlier accepted due to regulatory need.

HCAHPS

Hospital Consumer Assessment of Healthcare Providers and Systems

This is the only PRO instrument endorsed by CMS; it is required in the Medicare Shared Savings Program. There are forty-five approved vendors/administrators, and more that are not officially approved. It scores very low on many of our criteria and would not be included if not for the CMS approval. It is self-administered only after discharge (via mail) or is taken by phone interview. http://www.hcahpsonline.org

SF-36

Short-Form-36 Health Survey

This survey is not oncology specific but has been very broadly used (with 11,000 listings in PUBMED for the search string “SF-36”). It has a fixed set of 36 questions, with shorter versions that have 12 and 8 questions (the SF-12 and SF-8), and a companion inventory that focuses on pain. It can be self-administered on paper or computer or taken via interview. The SF-36 was originally developed by the Rand Corporation, which sold the commercial rights. Rand still makes the original version available as a free, public domain instrument.  http://www.rand.org/health/surveys_tools/mos/mos_core_36item.html

FACT-G

Functional Assessment of Cancer Therapy–General

The FACT-G was developed for use during treatment rather than clinical trials. It is applicable to all cancer tumors (though only three cancers were involved in its initial development: breast, lung, and colorectal). The FACT-G is a core set of metrics, with many different add-on sets designed for negative health affects in various cancers. It is brief, self-administered on paper (computer-based versions are being developed, according to the steward organization), or taken by interview (p2p or phone). www.facit.org

PROMIS

Patient Reported Outcomes Measurement Information System

PROMIS is a government program, funded by NIH, but not yet officially endorsed by CMS, AHRQ, or NQF. It is not oncology-specific, but it is very flexible; the user can select from existing core PRO sets and individual questions, as well as add questions of their own creation. It is free and hosted on the web, for use by researchers and clinicians. Users have their own secure databases, where they develop the sets they wish to use. The surveys can be self-administered on paper or online and also taken via interview (p2p or phone). Brevity and ease of use would depend on how customized you make it. It is a relatively new instrument but claims that the core set is well validated. http://www.nihpromis.org

MDASI

M.D. Anderson Symptom Inventory

The MDASI is oncology-specific and was developed for clinical and research use, with many subsets for different cancers. It is brief and can be self-administered (paper) or taken by interview (p2p or phone). It is relatively new (2000), but appears to be well validated. It is difficult to assess how broadly it has been used. (Searching PUBMED for “MDASI” reveals only 51 articles, and there are no hard data available that indicate the breadth of use of any PRO in clinical care.)  http://www.mdanderson.org/education-and-research/departments-programs-and-labs/departments-and-divisions/symptom-research/symptom-assessment-tools/m-d-anderson-symptom-inventory.html

Conclusions

Our selection criteria have given us a reasonable start; we have several useful PRO instruments to explore further. Dr. Lohr’s expert opinion is certainly true – the developers and stewards of PROs should make more effort to have them approved by NQMC and NQF, and those organizations should do more to facilitate the process. It would be a great benefit to hospitals, ACOs, and other providers to have a list of endorsed PRO metrics from which to choose. There are too many sets and too many vendors competing for the top hits on Google, and the most effective at cadging links are not necessarily the organizations most oriented to patient health and quality improvement over operations and ratings.

It is also true the CMS must make an effort to endorse and require PROs that are more focused on quality improvement in both patient health outcomes and clinical pathway processes. The financial carrot and stick that CMS provides cannot be ignored in the drive to move PROs to a more mature state of development. This is underscored by a study published on February 12, 2012 in the Archives of Internal Medicine entitled The Cost of Satisfaction: A National Study of Patient Satisfaction, Health Care Utilization, Expenditures, and Mortality. (Joshua J. Fenton, MD, MPH; Anthony F. Jerant, MD; Klea D. Bertakis, MD, MPH; Peter Franks, MD; Arch Intern Med. 2012;172(5):405-411. doi:10.1001/archinternmed.2011.1662. http://archinte.jamanetwork.com/article.aspx?articleid=1108766).

Noting that “…the relationship between patient satisfaction and health care utilization, expenditures, and outcomes remains ill defined…,” the authors conducted a study of seven years’ worth of data from the national Medical Expenditure Panel Survey. What they found was that “…higher patient satisfaction was associated with less emergency department use but with greater inpatient use, higher overall health care and prescription drug expenditures, and increased mortality.” In fact, the highest patient satisfaction quartile was 26% more likely to die compared to the lowest quartile.

This bald statistic has been seized on by some bloggers as a clear sign that PROs – at least those related to patient satisfaction – do not indicate healthcare quality. That may be true, but we can’t make that claim without first trying to fully understand the results of the study – as we would with any quality metric before acting on it. There are many questions we must ask. Were the survey questions focused on hospitality and patient experience or on health status? Were the results consistent across provider? Were satisfied patients more or less involved in the decisions regarding their treatment? Are highly satisfied patients more complacent, and thus more likely to accept whatever is offered? Are they more likely to accept their fate and not struggle against their disease? The fact is that these results could indeed show that satisfaction is a powerful tool for improving healthcare quality if we can be sure we are reading them correctly. Then we can design an appropriate adjustment to our treatments so that what we now call satisfaction is no longer an indicator of increased mortality. Or we might find that we simply need a better tool for measuring satisfaction; for example, a tool that measures health states not only before, during, and after treatment, but also against the patient’s expectation of what the outcomes should be.

In Better, Dr. Gawande describes a visit between a cystic fibrosis patient and doctor, the head of the CF clinic with the best patient outcomes by far in the U.S. The patient’s scores on several important measures had dropped, and the doctor was trying to discover why. He did what doctors always do in a one-on-one clinical situation: He looked at the scores and then he started to ask questions. In this case, he listened intently and asked more questions, until he uncovered where the patient had strayed from her treatment regime. In other words, the doctor was using PROs, made up on the fly for the specific disease, patient, and treatment pathway.

The patient, a teenager going through all of the changes and rebellions that that age brings on, balked at the discipline the doctor was asking of her, and he replied, “We’ve failed … it’s important to acknowledge when we’ve failed.” With that acknowledgement – and with both of them sharing the failure – they began to work out the adjustments she needed to make to get back on track with her treatment.

A PRO survey cannot have that level of sensitivity or insight, but a well-designed survey used in the appropriate situation can reveal when a treatment pathway is failing, and a careful analysis of the results can lead to measurable quality improvement, if not perfection.

Climbing Mt Moosilauke – with the Kilimanjaro Team

       

Climbing Mt Moosilauke – with the Kilimanjaro Team

The Prouty Mountaineering Program
(the first Prouty Challenge Event benefitting Dartmouth-Hitchcock Norris Cotton Cancer Center)

September 24, 2012

Wes Chapman

 

Climbers enjoying lunch on the summit of Mt. Moosilauke

The concept at the heart of The Prouty is simple – get people to engage in the outdoors and raise money to fight cancer for our NCI-designated comprehensive cancer center. This past Sunday was the first team outing for the gang slated for the December climb of Kilimanjaro – the highest mountain in Africa. After all Audrey Prouty (for whom the event is named) was from Warren, NH – home of Mt. Moosilauke – and I’m sure that she would have whole-heartily approved.

Brad & Ann Taylor lunching at the summit

Cancer is ultimately a disease about people – those fighting the disease, those providing care, and those who have passed on. We conceived the Prouty Mountaineering Program with a very simple premise; honor those people.

Mountains are a very special place – particularly very high mountains. The beauty, the isolation and the simple elevation combine into a unique spiritual experience.

Our thesis in the Prouty Mountaineering Program is really simple – go climb the highest mountains that you can find, get to the top, and honor cancer survivors, care givers and the victims of the disease. On or around December 20^th of this year we’ll have a team of 6 mountaineers to the top of Kilimanjaro to do just that.

A friend and climbing partner lost his wife this year to pancreatic cancer, and hers is the first name that I’ll honor at the top of Africa – flying a yellow ribbon from the top of Kilimanjaro – a mountain very much loved (and frequently climbed) by her family. I hope that in some way it helps with the loss.

 

Hannah Green, Wes Chapman & Betsy Chapman

We were delighted to have Hannah Green come along on the hike with us this weekend. Hannah is a Junior at Northfield Mount Hermon, and has been deeply touched by cancer in a loved one. She helped as an intern at the Prouty this year, and hopes to come along with us next year on the next Kilimanjaro climb. In addition to being a terrific student, Hannah is an accomplished cross country skier, and was merciful to the rest of our hiking team – she waited for us old fogies on the way up and down.

If you have someone that you would like to honor at the top of Kilimanjaro, please let me know who, how you would like them honored, and especially if mountains and natural beauty were important to them – to do this job right, it really helps to know the story (send to mwestonchapman@gmail.com). If you want to donate directly, please see the Prouty page at

http://reachforthepeaks.kintera.org/faf/donorReg/donorPledge.asp?ievent=1019697&lis=1&kntae1019697=CBA0B3B1DEB84C83B93451527E226A8B&supId=365314166.

Please make a donation as you see fit – all amounts great and small are really appreciated. Anything that we can do to support people in active treatment we will try to accomplish – signs, poems songs – you name it. Amazingly, there is good cell service on areas of the mountain and we will get photos, audio and video out for the support of patients in active treatment ASAP.

In the meantime, if you would like to come along on a Prouty prep hike, just drop me a line at the email above – we are out almost every weekend, and we really enjoy meeting new climbers.

Remember, it’s all about people.

All the Best from Kilimanjaro

Tax Refugees, the Buffett Rule and Emergent Phenomena

September 18, 2012

Wes Chapman

“Capital goes where it’s welcome and stays where it’s well treated”

Walter Wriston

 

I was struck by a recent article (August 29,2012) in the Wall Street Journal highlighting the reincorporation of US firms in various offshore venues to reduce their income tax burden – highlighting such American stalwarts as Eaton Corp, Transocean, Aon and Weatherford. What struck me was that this relocation for tax purposes would qualify as news to anyone. Well run American corporations have used a variety of international tax strategies to their advantage since the founding of the Republic, often forcing wholesale revision of the existing tax code to bring matters back to equilibrium – most spectacularly in 1913 with the passage of the 16^th Amendment and the introduction of the income tax itself.

Why an Income Tax

Prior to 1913, the Federal Government squeaked by on an amazingly complex series of tariffs on imported goods – which averaged 40% pre-1913 and were lowered to 26% post income tax. The high tariffs had their own Laffer curve type impact; reducing trade, lowering tax revenue, increasing domestic corporate and labor power, and infuriating our trading partners. On balance, a top marginal rate of 7% – the top rate in 1913 – looked like a pretty good deal relative to the tariff based alternative.

Interestingly, the original 1913 income tax code made no provisions for capital gains rates, dividend rates, unearned income (remember that concept fellow tax geeks?) and the like. Specifically it provided for taxation of:

“subject only to such exemptions and deductions as are hereinafter allowed, the net income of a taxable person shall include gains, profits, and income derived from salaries, wages, or compensation for personal service of whatever kind and in whatever form paid, or from professions, vocations, businesses, trade, commerce, or sales, or dealings in property, whether real or personal, growing out of the ownership or use of or interest in real or personal property, also from interest, rent, dividends, securities, or the transaction of any lawful business carried on for gain or profit, or gains or profits and income derived from any source whatever”

It seems pretty simple and it was. Within 30 years the top marginal rate for individuals had exploded to over 90%, and did not settle down back out of the more reasonable level of 28% until the Act of 1986 brought a temporary flood of order and sanity to the Tax Code. It stayed at those levels only for two years before the agents of entropy – lobbyists and tax specialists – worked their magic and began the tradeoffs of special treatment (think special deductions and credits) versus marginal rate increases which are the hallmark of our system today.

Chief among these putative inequities is the capital gains tax rate of 15% – the foundation of the simple logic behind the Buffett rule – billionaires should logically pay at least the same marginal rate as their secretaries in any fair tax system – particularly one which bills itself as “progressive”.

International tax codes as competitive Emergent Phenomena

As best noted by Mr. Wriston at the beginning of this paper, capital is free to flow wherever it pleases – typically places with the happy prospects of big returns and low taxes. Tax codes have become terrific methods for countries to attract investment capital and get it to stick around. Capital can flow to new markets in a way that labor cannot. Foreign capital is welcome in markets in a way that immigrant labor is never welcomed.

As a result, it is feasible to tax income on labor in a way that capital would never stand for. Consider the tax rates shown below for some of our trading partners:

Country	Top   Individual Rate	Top   Corporate Rate	Capital   Gains Rate	Value   Added Tax Rate
United   States	35%	39%	15%	0%
Ireland	41	10-25	25	9-23%
United   Kingdom	50	23	28	20
Canada	29	15	22	5
Japan	40	40	20	5
China	45	25	59	17
Mexico	29	28	30	16
Germany	45	30	28	19
India	33	10	15	NA

 

I have highlighted the highest rates in red, and the lowest rates in green. Not too surprisingly, those who can prefer to have capital gains taxed in the US – we have the lowest rates in the group. Ireland, Canada and India are great places to incorporate, but the poor unfortunates living in the UK and Germany are effectively subsidizing low corporate tax rates with very high individual rates and high value added taxes. It is important to note that very low capital gains rates are a recent phenomenon in the US.  As recently as 1989 they were set at the same level as the maximum earned income rate – specifically to address the tax rate disequilibrium that Mr. Buffett finds so distasteful.

Not all tax systems are created equal – They emerge in response to local and international forces

In the US we really hit our corporations and hit high earners fairly hard – in exchange for very low capital gains rates and the unique position of no VAT. The VAT is “regressive” and is considered antithetical to a consumer based economy. In a cynical view, we tax the hell out of high end workers and corporations to subsidize shop-a-holics and billionaires. Not too surprisingly, we have a relative surplus of both of the later, and fairly cranky wage earners and corporations – and the corporations can do something about it; as noted in the WSJ article, they move to a different venue.

Ant Hills and Taxes – Both Emergent Phenomena

Tax codes are really instruments with real competitive policy implications for growth, savings, consumption and investment. Most importantly, no nation’s tax code can be considered in a vacuum – they tend to be self organizing over time to be structured very much alike – but with important differences responsive to local sensibilities. The differences between them have major policy implications – both for internal purposes and external trade.

The classic emergent phenomena are ant hills; through the dedicated work of countless agents – ants – the ant hill emerges consistently – although always without a central plan, design or outside agent. Moreover, the world is full of different types of ants – but all of the successful ones build large hills – protected in their mounds while competing for food with their neighbors. International tax codes are much the same – with tax attorneys and accountants substituting for the ants and countless piles of paper substituting for the anthills – the phenomena are the same – and the metaphor simply compelling. In the case of tax codes the competition is for votes domestically, and discretionary tax revenues internationally.

Emergent phenomena exist at the ragged edge where the entropy promised by the second law of thermodynamics meet systems that make order out of chaos – all without a plan or external agent. The most interesting characteristic about emergent phenomena are that they are almost always best described by the unintended consequences that they create – emergent functionality. Tax systems are ostensibly designed to raise money for governmental activities, but their emergent functionality is entirely trade, investment and consumption related.

As we enter the end game of the silly season of a Presidential election year, let’s not lose sight of the fact that we have surrendered our fiscal policy to a doomsday machine (the fiscal cliff), and substituted a hyper-aggressive monetary policy for any fiscal policy at all – creating a gigantic disequilibrium in the economy. We have frozen all lines of rational discussion about fiscal policy, and locked in place a tax code which is considerably distorted relative to our trade partners, particularly regarding taxes on consumption and the glaring inequities highlighted by Mr. Buffett. We have a bit of a mess on our hands.

We have ceased the natural evolution of the tax code – all emergent phenomena learn and evolve – and created an ossified mess, leaving us at a substantial competitive disadvantage relative to our trading partners. Next year will mark 100 years since the modern tax system began under the Underwood-Simmons Act, and it may be time for a second revolution. The economic impact of the emergent functionality of the tax code is stupendous, and the current tax code is a mess.

In 1913 the US operated under a tariff based tax system that protected certain domestic industries, discouraged investment, hurt consumers, discouraged investment, tremendously distorted trade flows and simply didn’t raise enough money. The folks that ran the US at that time had the courage and wisdom to try something different – which proved responsive and adaptive for nearly a century.

Today, our tax system is at least as bad as the mess in 1913, and has completely ceased to change in response to changing domestic requirements and international competition. The question is – do we have the guts to actually fix it?

Oncology Pathways and Metrics: A Taxonomy of Leading Oncology Organizations

Oncology Pathways and Metrics: A Taxonomy of Leading Oncology Organizations

By Wes Chapman, Steve Maker, and Mario Martinez

Purpose

This paper is a short catalog of organizations that we believe are the most significant clearinghouses of clinical pathways and quality metrics for oncology. Our goal is to provide some insight into the organizations that influence oncology clinical pathways and quality measures, by briefly describing what they specifically address, how they interact with each other, and their different approaches to improving oncology care.

Background

In the past decade, quality improvement has become a focus in health care, driven in large part by efforts at the Center for Medicare and Medicaid Services (CMS) to reduce Medicare and Medicaid payments, while simultaneously increasing the perceived value of health care services; in other words, improving patient outcomes. One component of the effort is to increase efficiency and reduce errors during treatment. Another is to document and promulgate best practices in clinical pathways by endorsing a chosen set of pathways as guidelines for approved practice. These two components are linked by quality metrics that measure how well the chosen clinical pathway has been followed and, in the fullest implementation, how well patient outcomes compare to those achieved by similar healthcare providers following the same pathways.

CMS has also announced plans to shift payments from a fee-for-service basis to a pay-for-performance basis (P4P), and has run trials to test the efficacy of the shift. In order to work, P4P requires healthcare providers to use CMS-approved clinical pathways and to document fidelity by using approved sets of quality metrics. CMS is choosing its approved pathways and metrics from a number of organizations, some of which also provide some form of certification for healthcare providers; essentially, an official stamp of approval that has the potential to raise a provider’s level of payment, not only from CMS but also from other payers.

Additionally, CMS, through its Center for Medicare & Medicaid Innovation, has begun large scale testing of Accountable Care Organizations (ACOs) and various Bundled Payment Initiatives (BPIs) targeted at specific medical procedures and conditions. In every case, the ACOs and BPIs are required to submit extensive quality reporting – on both process and outcomes. Under section 3022 of the Affordable Care Act, the Department of Health and Human Services has established the Medicare Shared Savings Program, which allows ACOs to receive up to 60% of any cost savings they achieve for Medicare beneficiaries, provided they also score well and show improvement on a specific set of 33 quality reporting and performance metrics. While the majority of the metrics are not specific to oncology, two are (screening for colorectal and breast cancers), and the current metrics set also includes patient evaluations of the performance of their physicians, including oncologists. Significantly, the program relies on at least one newly derived metric (an ACO-specific Consumer Assessment of Healthcare Providers and Systems survey), and it increases the performance requirements over the course of three reporting periods. Future iterations also call for the inclusion of more metrics focused on specialty care. In other words, the future of P4P will be more specific, more detailed, and more rigorous in its dependence on quality metrics.

Thus, it has become very important for healthcare providers to know which organizations produce and publish the approved guidelines for clinical pathways and quality metrics and which provide certification for quality in clinical practice. When P4P is finally implemented, these organizations will influence not only a provider’s revenues but also its reputation.

Making the Cut: the Anna Karenina Principle

Currently, there are hundreds of healthcare organizations developing clinical practice pathways or sets of quality measures or both. These include at least a hundred with some focus on oncology, which is our area of concern. Luckily, only a few of these organizations currently have the reach and stature to be recognized by CMS and private payers, which will make the search for accepted pathways and metrics much easier to complete. The hard step is the first one: identifying the key organizations.

We took direction from an unlikely source, Leo Tolstoy, who stated the situation this way:

Happy families are all alike; every unhappy family is unhappy in its own way. (From Anna Karenina)

There are hundreds of individual quirks that must all be right for a family to be happy, but if any one quirk is not right, dysfunction ensues. The same principle has been broadly adopted as a statistical methodology, and applies directly in taxonomy: To be included in the happy family of a species, an organism must express every characteristic in a specific set. Restated in terms of oncology organizations, the Anna Karenina Principle tells us that the key organizations will be the only ones that meet a specific set of criteria. We define these must-have characteristics as:

1)      Clearly focused on oncology (or with a subgroup focused on oncology)

2)      Provides a clearinghouse of clinical pathways or quality metrics or both

3)      Is frequently referred to or partnered with other healthcare organizations

4)      Has clear links to/from CMS

5)      Has a large or prestigious membership with national reach

6)      Makes its pathways and metrics available to the public

Using these criteria, we identified eight organizations that we can label as significant clearinghouses of oncology pathways or metrics or both. Two of these are governmental organizations: CMS and the Agency for Healthcare Research and Quality (AHRQ). The other six are non-governmental organizations that mostly take the form of professional associations or networks:

• American Society of Clinical Oncology (ASCO)
• American Society for Radiation Oncology (ASTRO)
• American College of Surgeons Commission on Cancer (ACS CoC)
• Association of Community Cancer Centers (ACCC)
• National Comprehensive Cancer Network (NCCN)
• National Quality Forum (NQF)

Obviously, some big names in healthcare are missing. The American College of Surgeons National Surgical Quality Improvement Program (NSQIP), for example, lacks an oncology focus. The AMA has endorsed oncology quality measures produced by other organizations, but it does not provide a clearinghouse. The American Cancer Society has the oncology focus, but also does not provide a clearinghouse.

That said, none of the eight key organizations has a perfect match on every characteristic, as the following table shows. AHRQ and the NQF are definitely clearinghouses, for example, with many pathways and metrics in their databases, while ASTRO and ACCC have but a few each. Some are better known and more often referred to than others. Then there is CMS, which we have included because it is the regulating body that will ultimately identify what pathways must be followed and what metrics must be collected in order to be certified for payment under Medicare/Medicaid (followed quickly by private payers). These differences are detailed in the catalog that follows, and made more obvious in a set of contrasting tables at the end of the paper. (There is a list of acronyms there, too.)

Taxonomy Table
	Oncology Focus	Clearinghouse	Referred to	CMS Link	Members, Reach	Open to Public
CMS	Subgroup	Sets payment   standards	Very frequently	N/A	N/A	Yes
AHRQ	Subgroup	Yes, many	Frequently	Yes	N/A	Yes
ASCO	Yes	Some	Very frequently	Yes	Yes	Yes
ACS CoC	Yes	Some	Frequently	Yes	Yes	Yes
ASTRO	Yes	Few	Infrequently	Yes	Yes	Yes
ACCC	Yes	Few	Somewhat frequently	Yes	Yes	Yes
NCCN	Yes	Some	Very frequently	Yes	Yes	Yes
NQF	Subgroup	Yes, many	Frequently	Yes	Yes	Yes

 

 

 

 

 

 

 

 

 

What You’ll Find There

All of the organizations use the web to announce and distribute their sets of pathways and metrics. In some cases, the websites contain an online, searchable database, and in other cases they provide a way to download their guidelines in a large PDF document. These differences are relatively minor. There are more serious usability issues to deal with.

Despite over a decade of discussion in journals, conferences, consensus groups, press releases, blogs, and governmental pronouncements, the healthcare community has made only slow progress on developing accepted sets of clinical pathways and quality metrics. The terminology has not even had time to settle on an accepted nomenclature. “Clinical pathways,” for example, are often referred to as “clinical practices,” and also as “protocols” and “treatment plans”. The most common term you’ll see to identify a set of endorsed clinical pathways is “guidelines”. For metrics, the most common term seems to be “quality measures,” but you will also see “quality indicators,” and both appear on the AHRQ website. Drilling down through the large AHRQ database can also be tricky, requiring close attention to topic areas and search terms.

A more fundamental problem is the relative incompleteness of the guidelines and particularly the measures, and in the links between them. In the best of all possible worlds, you would be able to search on a term like “staging metrics stage IV non–small-cell lung cancer” and immediately find one or two CMS-endorsed, evidenced-based, best-practice clinical pathways that clearly define all the steps in the treatment. In addition, each pathway would automatically be linked to an endorsed set of quality measures that will not only document adherence to the pathway and help to insure the best possible outcome, but also provide data to support quality improvement.

The system is not there yet, but there are indications that it is at least heading in that direction, and not in separate winding routes mapped out by each organization. These key players have been forming partnerships, both among themselves and with other healthcare and oncology organizations, to achieve a broader consensus of approval of their guidelines and quality measures. Perhaps the best example is a pair of simultaneous initiatives, one undertaken by ASCO and NCCN, the other by the ACS CoC, to develop quality measures for breast and colorectal cancer. The CoC submitted their measures to the NQF for endorsement as part of the NQF’s Cancer Project. The NQF is now facilitating a collaboration among the three organizations to synchronize the measures and present a unified set to the public. (For details, visit this page on the NCCN website: http://www.nccn.org/professionals/quality_measures/.)

We can only hope this trend continues and accelerates.

What You’ll Find Here

For each organization, we provide the following information.

• Name and relevant web addresses
• Mission statement and/or goals
• Membership requirements and number of members
• Certifications offered
• Key partnerships (regarding pathways, metrics, and accreditation)
• Journals and Newsletters
• Stance on patient education, palliative care, and multimodal care
• Pathways/Guidelines: purpose and general description
• Metrics: purpose and general description

A set of tables comparing basic data for each organization appears after the detailed descriptions.

The Family of Organizations

Center for Medicare & Medicaid Services (CMS)

http://www.cms.gov

http://www.innovations.cms.gov/

Mission Statement: CMS currently specifies reporting requirements through the Physician Quality Reporting System (PQRS), “a reporting program that uses both incentive payments and payment adjustments to promote reporting of quality information by eligible professionals.  The program provides a payment to practices with professionals who satisfactorily report data on quality measures for covered physician fee schedule services furnished to Medicare part B Fee-for-Service beneficiaries. In 2015 the program will also apply a payment adjustment to eligible professionals who do not satisfactorily report data on quality measures for covered professional services.” As described in the Background section, CMS has just initiated the Medicare Shared Savings Program, which requires ACOs to report specific quality measures and eventually achieve performance standards.

Memberships: There is no membership program per se. Physicians, groups, etc. who wish to take part must register and go through several steps to confirm eligibility. Technically, every provider in the U.S. and its territories that accepts Medicare/Medicaid patients will eventually need to take part in this or an equivalent program for P4P.

Certifications offered: None. CMS provides payment incentives for physicians who are board certified and take part in a certification maintenance program, but they endorse qualified certifying entities rather provide their own certification.

Key Partnerships: CMS endorses pathways and metrics developed by a number of organizations, along with qualified entities that provide board certification in a number of clinical areas. However, they do not themselves partner with other organizations to create pathways or metrics or to certify physicians.

Journals and Newsletters: None

Stance on Patient Education/Involvement: No stated position.

Stance on Palliative Care: Endorses metrics related to pain control, palliation, and end-of-life care.

Stance on Multimodal Care: Recent Bundled Payment Initiatives show an increasing awareness of and support for multimodal care; however, current regulations and programs do not fully support it in practice.

Pathways: CMS does not publish guidelines for clinical practice. Instead, it relies primarily on the National Guidelines Clearinghouse (NGC) maintained by AHRQ (http://guidelines.gov), and on the endorsements provided by the NQF.

Metrics: Purpose: To collect quality data documenting that physicians have followed prescribed pathways and are eligible for payment under the Medicare/Medicaid system. PQRS specifies both the financial carrot and stick to encourage physicians to collect and report this data. The physicians are under no requirement to use the data for any other purpose, such as quality improvement. The Medicare Shared Payments Program for ACOs does require care providers to meet specified performance standards and show improvement. As with pathways, CMS does not publish metrics, referring users to AHRQ’s National Quality Measures Clearinghouse (NQMC: http://qualitymeasures.ahrq.gov) and the NQF.

 

Agency for Healthcare Research and Quality (AHRQ)

http://www.ahrq.gov

http://guidelines.gov/index.aspx

http://qualitymeasures.ahrq.gov/index.aspx

Mission Statement: “To improve the quality, safety, efficiency, and effectiveness of health care for all Americans.  Information from AHRQ’s research helps people make more informed decisions and improve the quality of healthcare services.”

Memberships: No memberships; all information is free and accessible by the public. “Customers” include clinicians and other healthcare providers, consumers and patients, healthcare policy-makers at federal, state, and local levels, purchasers and payers, and other hospital officials.

Certifications offered: None

Key Partnerships:

Effective Health Care Program National Partnership Network (232 partners). “These organizations have joined us in promoting patient centered outcomes research in patient and professional communities across the United States. By becoming partners, they have become part of a growing partnership network committed to improving the quality of health care through informed decision making.” http://www.ahrq.gov/clinic/partners/partners.htm

Journals and Newsletters: Two digital newsletters, free to the public, register on the site

Research Activities (email updates that summarize latest findings from AHRQ-funded studies, announce AHRQ publications, funding opportunities, events, etc.)

Inside Track (email and online, provides news and developments from AHRQ’s Effective Health Care program)

Stance on Patient Education/Involvement: Actively promotes educating patients and involving them in decision-making.

Stance on Palliative Care:  No stated position. Various reports and presentations have addressed the issue, but they do not yet have categories for palliative care in their guidelines or quality measures clearinghouses. One advisory council member urged the group in 2011 to create a separate clearinghouse for end-of-life and palliative care practices.

Stance on Multimodal Care: No stated position.

Pathways: AHRQ hosts and maintains the National Guideline Clearinghouse (NGC), a database of evidence-based clinical pathway guidelines submitted by clinical research centers and professional clinical organizations. AHRQ does not create guidelines; it endorses them and makes them available to clinicians. Currently, there are 936 pathways found with the search text of “oncology or cancer”.

Purpose: “…to provide physicians and other health professionals, health care providers, health plans, integrated delivery systems, purchasers, and others an accessible mechanism for obtaining objective, detailed information on clinical practice guidelines and to further their dissemination, implementation, and use.”

http://guidelines.gov/index.aspx

Metrics: AHRQ hosts and maintains the National Quality Measures Clearinghouse (NQMC). As with the guidelines clearinghouse, AHRQ endorses metrics submitted by other organizations. AHRQ has also developed a set of metrics on its own, which are cataloged in the NQMC without any special priority or endorsement. Currently, the NQMC holds 332 measures that can be found with the search text of “oncology or cancer”. (For each clinical pathway guideline, the Guidelines Clearinghouse displays a link labeled “Related NQMC Measures”; however, it appears to return the same small set of metrics every time.)

Purpose: “Health care delivery measures are used to assess the performance of individual clinicians, clinical delivery teams, delivery organizations, or health insurance plans in the provision of care to their patients or enrollees. Population health measures are applied to groups of persons identified by geographic location, organizational affiliation or non-clinical characteristics, in order to assess public health programs, community influences on health, or population-level health characteristics that may not be directly attributable to the care delivery system.” The clearinghouse includes both types of measures, broken into these sub-groups: quality measures, related health measures, and efficiency measures. (More information on the Domain Framework and inclusion criteria will be found here:

http://qualitymeasures.ahrq.gov/about/domain-framework.aspx

 

American Society of Clinical Oncology (ASCO)

www.asco.org

Mission statement: ASCO is “a professional oncology society committed to conquering cancer through research, education, prevention and delivery of high-quality patient care.”

Vision statement: “All cancer patients will have lifelong access to high quality, effective, affordable and compassionate care; The most accurate cancer information will be available so that patients and physicians can make informed decisions about cancer prevention and treatment; Information we learn from every patient will be used to accelerate progress against cancer; Resources will exist to attract the best clinicians and investigators to provide optimal patient care and to conduct transformative research; ASCO will be recognized as the most trusted source of cancer information world wide.”

Memberships: Full member, Member in training, Allied Physician/doctoral scientist, Affiliated health professionals, Internal corresponding, Student/non-oncology resident (dues vary by category). Full members are licensed physicians or other health professionals at the doctoral level of a nation who devote a majority of their professional activity to cancer patient care and/or research. Number of members: 30,000 individual members from every oncology subspecialty.

Certifications offered: Quality Oncology Practice Initiative (QOPI) Certification Program

http://qopi.asco.org/certification

Key Partnerships:

• NCCN
• NQF
• ACS CoC
• ASTRO
• AMA
• PCPI
• ONS (Oncology Nursing Society)

Journals and Newsletters:

Journal of Clinical Oncology: Three times monthly (36 times a year); on the 1st, 10th, and 20th each month. Circulation: 23,809 (16,190 domestic, 7619 international; 20,653 member, 3,156 non-member)

Journal of Oncology Practices: Bi-monthly (6 times/year in odd-numbered months). Circulation: 16,883 (16,165 domestic, 718 international; 16,656 member, 227 non-member)

Stance on Patient Education/Involvement: Part of their vision statement.

Stance on Palliative Care: No stated position, but has metrics for palliative and end-of-life care

Stance on Multimodal Care:  No stated position

Pathways: Purpose: ASCO maintains a list of clinical pathway guidelines that “…address specific clinical situations (disease-oriented) or use of approved medical products, procedures, or tests (modality-oriented) … Topics for guidelines are selected on the basis of significant clinical or economic importance; presence of variations in patterns of, or access to, care; availability of suitable data; and ethical considerations.” Currently, there are 37 guidelines, sorted into these categories:

• Assays and Predictive Markers
• Breast Cancer
• Gastrointestinal Cancer
• Genitourinary Cancer
• Head and Neck Cancer
• Hematologic Malignancies
• Lung Cancer
• Melanoma
• Supportive Care and Quality of Life
• Survivorship
• Treatment-Related Issues

A full list of guidelines is available here:

http://www.asco.org/ASCOv2/Practice+%26+Guidelines/Guidelines/Clinical+Practice+Guidelines

Metrics: Purpose: To aid oncology practices in quality self-assessment.

Core oncology metrics (required for QOPI certification):

• Documentation of care
• Chemotherapy planning, administration, and treatment summary
• Pain assessment and control
• Smoking cessation
• Psychosocial support

Disease-Specific Modules:

• Breast (as applicable to practice)
• Colorectal (as applicable to practice)
• Non-Hodgkin’s Lymphoma (as applicable to practice)

Domain-Specific Modules:

• Symptom/Toxicity Management
• Care at the End of Life

(Download this document to see the full list of certification metrics: http://qopi.asco.org/Documents/QOPICertificationMeasuresasof3.2012_000.pdf)

 

American Society for Radiation Oncology (ASTRO)

http://www.astro.org

Mission statement: Dedicated to improving patient care through education, clinical practice, advancement of science, and advocacy.

Memberships: Active members must be physicians certified in radiation oncology or therapeutic radiology, or a radiation physicist certified in radiological physics or therapeutic radiological physics, or a radiation or cancer biologist with a PhD who dedicates significant time to radiation oncology or sciences. Other types of membership include affiliate, international, corporate, etc. Number of members: More than 10,000.

Certifications offered: Accreditation offered jointly with American College of Radiologists (ACR)

Key Partnerships:

• AMA
• ASCO
• Physician Consortium for Performance Improvement (PCPI)
• American Association of Physicists in Medicine (AAPM)
• Affiliates: Association of Residents in Radiation Oncology (ARRO), Society of Chairmen of Academic Radiation Oncology Programs (SCAROP), ASTRO Radiation Oncology Nurses (ARON), and Association for Directors of Radiation Oncology Programs (ADROP).

Journals and Newsletters:

Red Journal: Published online 15 times per year; Monthly unique visitors: 15,681; Email distribution: 10,823

Practical Radiation Oncology (PRO): Published quarterly; Circulation: 6,705

ASTROgram: weekly e-mail to members

ASTROnews: quarterly emagazine

Stance on Patient Education and Involvement: No formal statement; however the ARON affiliate section of the web site has patient education resources, and they maintain a separate patient website, www.RTAnswers.org, “…a resource for patients and caregivers to find detailed information about radiation therapy; what to expect before, during and after treatment; questions for patients to ask about radiation safety and a dictionary to help patients with terms they will hear.”

Stance on Palliative care: No stated policy, but two of their five guidelines are related to palliative treatment.

Stance on Multimodal Care: Participates in two multidisciplinary symposiums

Pathways: Their website has separate sections on Guidelines and Best Practices; both appear to be in their infancy. The guidelines section currently has 5 guidelines (Breast Cancer, Palliation (2), Thoracic Malignancies, and Brain Tumor). The best practices page has a stated purpose but no content. (Development is scheduled to start some time in 2012.)

https://www.astro.org/Clinical-Practice/Guidelines/Index.aspx

https://www.astro.org/Clinical-Practice/Best-Practices/Index.aspx

Metrics: Actively promotes use of CMS’ PQRS measures. In addition, ASTRO partnered with the AMA, ASCO, and PCPI on 10 quality measures that are included in the AHRQ’s National Quality Metrics Clearinghouse.

 

American College of Surgeons, Commission on Cancer (ACS CoC)

www.facs.org

http://www.facs.org/cancer/

Mission statement: “The American College of Surgeons is dedicated to improving the care of the surgical patient and to safeguarding standards of care in an optimal and ethical practice environment.”

“The Commission on Cancer (CoC) is a consortium of professional organizations dedicated to improving survival and quality of life for cancer patients through standard-setting, prevention, research, education, and the monitoring of comprehensive quality care.”

Memberships: CoC membership is composed of 100 individuals who are either surgeons representing the American College of Surgeons or representatives from the 49 national, professional organizations or member organizations affiliated with the CoC. Applicants must demonstrate involvement in one or more of the following areas within the field of oncology: Cancer registration and/or surveillance, Cancer patient care services, Patient advocacy (oncology-focused across all cancers), Cancer control & prevention efforts, Professional education in oncology, and Oncology research. In addition, the CoC’s Cancer Liaison Program is a network of 1,500 Cancer Liaison Physicians serving CoC-accredited cancer programs.

Certifications offered: Yes. “The CoC Accreditation Program encourages hospitals, treatment centers, and other facilities to improve their quality of patient care through various cancer-related programs. These programs focus on prevention, early diagnosis, pretreatment evaluation, staging, optimal treatment, rehabilitation, surveillance for recurrent disease, support services, and end-of-life care.”

Key Partnerships:

• Alliance for Clinical Trials in Oncology (ACTO)
• ASCO
• NCCN
• NQF

Journals and Newsletters:

CoC Flash: Published monthly online and via email (by free subscription)

Stance on Patient Education/Involvement: No stated position; however, they provide some informational resources for patients.

Stance on Palliative care: Standards in their accreditation program focus on palliative and end-of-life care.

Stance on Multimodal Care: Standards in their accreditation program focus on encouraging multimodal care. In their own words, “Recognizing that cancer is a complex group of diseases, the CoC Cancer Program Standards promote consultation among surgeons, medical and radiation oncologists, diagnostic radiologists, pathologists, and other cancer specialists. This multidisciplinary cooperation results in improved patient care.”

Pathways: “The Commission on Cancer does not endorse any specific guideline, but has elected to make guidelines from various national organizations available through this Web site for informational purposes only. Inclusion on this Web site does not constitute a guarantee or endorsement of these guidelines by the Commission on Cancer or the American College of Surgeons.”

http://www.facs.org/cancer/coc/cocpracguide.html#

That said, the standards that the CoC sets for accreditation include both pathways and related metrics (see below). Finally, the CoC maintains a Best Practices Repository that contains “Tools and best practice resources designed to help cancer programs meet the CoC Cancer Program Standards” in order to become accredited or maintain accreditation.

http://www.facs.org/cancer/coc/bestpractices.html

Metrics: The primary set of metrics is part of the extensive requirements for accreditation (core metrics). They are described in detail on pages 63-92 in this document:

http://www.facs.org/cancer/coc/cocprogramstandards2012.pdf

The CoC developed a separate small set of metrics – the Quality of Care Measures – that focuses on breast and colorectal cancer. These standards parallel a set developed jointly by ASCO and NCCN. Facilitated by the NQF, the three organizations have agreed to synchronized their developed measures to ensure that a unified set are put forth to the public.

 

Association of Community Cancer Centers (ACCC)

www.accc-cancer.org

Mission statement: “The ACCC is a national multidisciplinary organization that promotes the entire continuum of quality cancer care for our patients and our communities.” Its core purpose is “to be the leading education and advocacy organization for the cancer team.”

Memberships: There is an application process, but the organization is open to almost anyone involved in the broad area of cancer research, diagnosis, treatment, care, administration, and support. There are 17,000 individual members, 28 chapters, and 700 cancer programs affiliated with the ACCC.

Certifications offered: No

Key Partnerships:

• CoC
• National Cancer Advisory Board (NCAB)

Journals and Newsletters:

Oncology Issues magazine: Published bimonthly by subscription; circulation: 16,881

ACCConnect: Bi-weekly newsletter distributed to members via email and available on the website.

Stance on Patient Education/Involvement: No stated policy. They have a publication called the “Patient Assistance Guide” that focuses on supplementary services and reimbursement resources.

Stance on Palliative care: Their cancer program guidelines discuss palliative care “…to assist patients in achieving maximum comfort and relief of suffering at the end of life.”

Stance on Multimodal Care: Their cancer program guidelines emphasize the “multidisciplinary Team.”

Pathways: None. The ACCC publishes a set of Cancer Program Guidelines that are structural rather than clinical: “The Association of Community Cancer Centers Cancer Program Guidelines have been established to assist cancer programs that want to develop and/or maintain a comprehensive interdisciplinary program that meets the needs of cancer patients and their families. These guidelines were developed to reflect the optimal components for a cancer program. The guidelines are not intended to act as an accrediting or credentialing mechanism and are not a list of standards, such as those published by the American College of Surgeons Commission on Cancer. The guidelines should not be a surrogate for independent medical judgment; they serve only as the term implies: as guidelines to help programs meet the optimal attributes.”

Metrics: None. The final section of their cancer program guidelines names Quality Improvement as a requirement for a successful program and describes what a QI system should look like in the broadest terms. No actual metrics are included.

 

National Comprehensive Cancer Network (NCCN)

www.nccn.org

Mission Statement: “Dedicated to improving the quality and effectiveness of care provided to patients with cancer.” Develops resources to present information to those who deliver health care. They help promote continuous quality improvement through the creation of clinical practice guidelines. NCCN’s primary goal is to “…improve the quality, effectiveness, and efficiency of oncology practices so patients can live better lives.”

Memberships: All member institutions are major cancer centers; there are currently 21 members. Member institutions pay dues that support the development of their guidelines, which are available to the public for free.

Certifications offered: No

Key Partnerships:

• ASCO
• NQF
• ACS CoC
• ASTRO
• NCCN Health IT Licensees: 13
• NCCN website supporters: 5

Journals and Newsletters:

• NCCN Flash Updates™ – a timely notification of changes and updates to the NCCN guidelines
• eBulletin newsletter: Every other Monday; Circulation 75,000-plus, including 26,000-plus physicians (for all registered U.S. users on nccn.org)
• Journal of the National Comprehensive Cancer Network (JNCCN): Monthly, by subscription; Circulation 23,143 (21,00-plus physicians, physician assistants, and nurse practitioners)

Stance on Patient Education/Involvement: Has guidelines created specifically for patients, with a separate web site aimed specifically at patients, families, and caregivers. (www.nccn.com)

Stance on Palliative care: Has guidelines specific to palliative care.

Stance on Multimodal Care: According to the website, NCCN member institutions pioneered the multidisciplinary teams approach.

Pathways: Purpose: To show consensus from leading cancer treatment institutions on how to treat specific kinds of cancer. Metrics and pathways are categorized based on level of evidence and degree of consensus. The guidelines are free, but visitors to the website must register in order to view or download them. The guidelines are sorted into these categories:

• Treatment of cancer by site (48 diagnostic areas in 6 procedural areas)
• Detection, prevention, and risk reduction
• Supportive care (includes palliative care)
• Age-related recommendations (adolescent/young adult and senior)
• Guidelines for patients

Metrics: Purpose: The same as for Pathways. NCCN partnered with ASCO to develop quality metrics for breast and colorectal cancer, and the two are now working with the ACS CoC and NQF to bring their separate guidelines in these areas into sync. Details are given on this web page: http://www.nccn.org/about/news/newsinfo.asp?NewsID=79.

 

National Quality Forum (NQF)

www.qualityforum.org

Mission statement: “The National Quality Forum is a nonprofit organization that operates under a three-part mission to improve the quality of American healthcare:

Building consensus on national priorities and goals for performance improvement and working in partnership to achieve them

Endorsing national consensus standards for measuring and publicly reporting on performance

Promoting the attainment of national goals through education and outreach programs”

Memberships: Membership is open to healthcare organizations with an interest in quality improvement. Individuals in the field who are not currently employed by such an organization may apply as individuals. The membership includes consumer organizations, public and private purchasers, physicians, nurses, hospitals, accrediting and certifying bodies, supporting industries, and healthcare research and quality improvement organizations. Current number of member organizations is 370.

Certifications offered: None

Key Partnerships:

• The National Priorities Partnership (NPP) – “…offers consultative support to the Department of Health and Human Services on setting national priorities and goals for the HHS National Quality Strategy.” (Currently 51 members)
• The Measure Applications Partnership (MAP) – “…provides multi-stakeholder input to HHS on the selection of performance measures for public reporting and payment reform programs.” (Approx. 110 members)
• Dept. of Health and Human Services (HHS)
• AHRQ
• ACS CoC
• ASCO
• NCCN

Journals and Newsletters: None

Stance on Patient Education/Involvement: The website has topic section focusing on Patient and Family Engagement, and they have announced the recent endorsement of 45 practices to guide healthcare systems in providing culturally competent care; however, there are no clearly identifiable standards related to patient education.

Stance on Palliative care: Endorses measures that deal with palliative care. Members have access to a “National Framework and Preferred Practices for Palliative and Hospice Care Quality.”

Stance on Multimodal Care: Have standards regarding different types of treatment, including surgery, chemotherapy, and hormonal therapy.

Pathways: Currently none, although the introduction to their performance standards includes this statement: “NQF also endorses other types of consensus standards, including preferred practices and measurement frameworks. Information about these other types of standards will be added in the coming months.”

Metrics: NQF endorses quality measures submitted by other organizations, which it makes publicly available in an online database called the National Voluntary Consensus Standards for Quality of Cancer Care. Stated purpose: “…to facilitate the comparison of cancer care providers for the purpose of accountability, quality improvement and surveillance and can be used by consumers, providers, federal and private purchasers and researchers.”

The NQF’s partnerships with HHS make it a key player in healthcare quality improvement. The National Quality Measures Clearinghouse maintained by AHRQ has a navigation link specifically for NQF endorsed measures. (Currently, AHRQ shows 444 NQF endorsed measures, while a search on the NQF site shows 734.)

 

Comparative Tables

These three tables provide a quick comparison among the members of our taxonomy. The data points are all taken from the preceding descriptions of the organizations.

Comparative Table:   Members and Partners
	Professional Members	Member Institutions	Key Partners
CMS	–	–	AHRQ, NQF
AHRQ	–	–	CMS, NQF, plus 232 in   the EHC program
ASCO	30,000	–	ASTRO, CoC, NCCN, NQF,   PCPI, ONS
ACS CoC	1,600	49	ASCO, NCCN, ACCC, ACTO
ASTRO	10,000+	–	ASCO, ACR, AMA, PCPI,   AAPM, plus 4 affiliates
ACCC	17,000	700 affiliated cancer programs	CoC, NCAB
NCCN	–	21	ASCO, CoC, NQF
NQF	Not Available	370	CMS, ASCO, AHRQ, CoC,   NCCN, NPP, MAP, HHS

 

 

Comparative Table: Reach
	Accreditation or Certification	Endorsed by health plans	Newsletters/Journals
CMS	No: endorses certifying boards	–	None
AHRQ	No	Endorsed by CMS	2 digital newsletters: Research Activities, Inside   Track
ASCO	QOPI: 138 Certified, 780 participating	Yes: more than 60	Journal of Clinical Oncology Journal of Oncology Practices
ACS   CoC	Yes (ACS): 1,500 certified	No	CoC Flash
ASTRO	Yes, with ACR: 300+	No	Red Journal, Practical Radiation Oncology, ASTROgram, ASTROnews
ACCC	No	No	Oncology Issues, ACCConnect
NCCN	No	No	NCCN Flash Updates, eBulletin, Journal of the NCCN
NQF	No	Endorsed by CMS	None

 

 

 

 

Comparative Table: Pathways and Metrics
	Pathways/Metrics	For Patient ed & involvement	For Palliative care	For Multi-modal care
CMS	Endorses metrics	Yes	For end of life	Yes
AHRQ	Develops and endorses both	Yes	For end of life	Yes
ASCO	Develops both	Only a few	Yes	Some
ACS   CoC	Lists but does not endorse. Includes both in   accreditation standards	Some patient resources	Some	Some
ASTRO	A few guidelines. Promotes PQRS; 10 metrics developed   with PCPI on NQMC	Some patient resources	Yes	No
ACCC	Structural guidelines, no metrics	Limited	Yes	Yes
NCCN	Develops both: a few metrics so far	Yes: extensive resources	Some	Yes
NQF	Endorses: many metrics, few pathways	Some	Yes	Yes

 

Conclusion

The eight chosen organizations that meet the requirements of our taxonomy show an encouraging similarity of purpose: All of them agree that the use of evidence- or consensus-based pathways and metrics will lead to better patient care and outcomes. It is also encouraging that, with two organizations focused on medical oncology, one on surgical oncology, and one on radiation oncology, all of them endorse the concept of multimodal treatment plans. Most of them also make a clear statement in support of patient education and involvement, and some provide extensive patient resources. This is strong evidence for positive trends toward quality improvement in treatment and also toward more patient-centric care.

Our taxonomy also reveals a pyramidal hierarchy in the development and endorsement of pathway and metrics that puts the largest payer for healthcare in the world – CMS – in a key role in selecting pathways and metrics that correspond to payment:

          

As the regulating body, CMS specifies that treatment must meet certain standards, to ensure meeting payment requirements. CMS chooses which quality measurement tools will be used to demonstrate that the standards are being met, drawing from the endorsed catalogs maintained by AHRQ and NQF. These two clearinghouses, in turn, choose the best practices submitted by the research centers and clinics that make up the broad base of the pyramid.

The organizations at the base are labeled “stewards” of the pathways and metrics that they develop; by implication, they will watch over their products and update or retire them as new evidence comes to light. The remaining five organizations in our taxonomy – ASCO, ACCC, ACS CoC, ASTRO, and NCCN – form an upper tier among the stewards for oncology pathways and metrics. They endorse metrics submitted by their members and by affiliated organizations of smaller reach and output.

As a final note, it is striking that, of the thousands of pathways, metrics, and patient educational materials developed at the level of the steward organizations, CMS has reduced the number actually utilized to determine and/or influence payment to a few dozen. For metrics and pathways to have a broad-based impact, this number will have to increase dramatically, and pathways will have to become much more broadly utilized to influence payment.

Next

Much has been made of patient reported outcomes (PROs), but there has been very little systematic analysis of who promulgates PROs, what they are used for, and how they might be organized into a rational taxonomy. Stay tuned for the next paper, which will look at these issues.

We would like to acknowledge the help in research and editing from     Dean Whitlock, writer, author, and auctioneer (deanwhitlock.com).